Auto-Titrating Oral Appliance for Sleep Disordered Breathing

项目总结/摘要 拉什河研究公司（RRR）提出开发一种自动滴定口腔器具， 睡眠呼吸障碍（SDB）的治疗。SDB是由气道阻塞引起的， 与美国四种最昂贵的疾病直接相关：心脏病，糖尿病，肥胖症， 癌研究表明，SBD患者过早死亡的可能性是正常人的三倍。电流 治疗设备，如CPAP、手术和传统的非自动滴定口腔器具是最常见的。 SBD的常见治疗方法，CPAP被认为是金标准。尽管30年来 CPAP商业化，90%的潜在美国和全球SDB治疗市场仍然未经治疗。 缺乏CPAP的耐受性导致用户依从性差。口腔下颌前移矫治器 通常由牙医提供，适合和滴定，通常是不成功的患者的替代品。 有CPAP或轻度SDB的经验。然而，滴定过程可能需要多次访问 牙医在几个月内，牙医缺乏对期间和之后的依从性和有效性的反馈 滴定颞下颌关节（TMJ）的炎症是由固定和连续的人工 也可能发生下颌骨的前移。所提出的连接自动滴定、SDB传感、口服 设备可以缓解滴定过程的问题，并进行优化，以提供最少的治疗 以提高用户的安全性和舒适性。RRR和合作者提出， 通过开发原型矫治器和演示， 在对患有SDB的人进行的过夜人体研究中，降准已经集结了一个高素质的 睡眠和口腔医学专家和经验丰富的医疗设备设计师团队来实现这些目标。

Project Summary/Abstract Rush River Research Corp. (RRR) proposes to develop an auto-titrating oral appliance that fits fully-in-the-mouth for Sleep Disordered Breathing (SDB) therapy. SDB, resulting from airway obstruction, is directly linked to the four most costly diseases in the United States: heart disease, diabetes, obesity, and cancer. Research has shown that SBD sufferers are three times more likely to die prematurely. Current therapeutic devices, such as CPAP, surgery, and traditional non-auto-titrating oral appliances are the most common therapy approaches to SBD, with CPAP being considered the gold standard. Despite 30 years of CPAP commercialization, 90% of the potential U.S. and worldwide markets for SDB therapy remain untreated. Lack of toleration of CPAP leads to poor compliance among users. Oral mandibular advancement appliances typically provided, fit, and titrated by dentists are often an alternative for patients with unsuccessful experiences with CPAP or with mild SDB. However, the titration process can require multiple visits to the dentist over several months and the dentists lack feedback on compliance and efficacy during and after titration. Inflammation of the temporomandibular joint (TMJ) resulting from the fixed and continuous artificial advancement of the mandible can also occur. The proposed connected auto-titrating, SDB sensing, oral appliance can mitigate issues with the titration process and be optimized to provide minimum therapy necessary to improve user safety and comfort. RRR and collaborators propose to show feasibility of a fully-in-the-mouth micro manipulating oral appliance by developing a prototype appliance and demonstrating functionality in an overnight human study of people suffering from SDB. RRR has assembled a highly qualified team of Sleep and Oral Medicine experts and experienced medical device designers to achieve these goals.